12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXIDENT DENTURE
FDA 510(k)
FDA Class 2
·Dental
KIT, RIA, GENTAMICIN SULF.
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEARTMATE II LVAS, EUROPE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 7, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2015
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code ONU·November 11, 2025
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·April 19, 2023
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 19, 2023
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025